98 Participants Needed

Ensartinib for Cancer

Recruiting at 131 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

Yes, you may need to stop some medications. You cannot take other anti-cancer agents, investigational drugs, or strong CYP3A4 inducers/inhibitors. If you're on corticosteroids, you must be on a stable or decreasing dose for at least 7 days before enrolling. Anti-GVHD agents post-transplant are also not allowed. Check with the study team for specific guidance on your medications.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before enrolling. You cannot be on other anti-cancer agents, investigational drugs, or strong inducers or inhibitors of CYP3A4. If you're on corticosteroids, you need to be on a stable or decreasing dose for at least 7 days before enrolling.

What data supports the idea that Ensartinib for Cancer is an effective treatment?

The available research does not provide any data on Ensartinib for Cancer. Instead, it focuses on another drug, Sorafenib, which is used for treating different types of cancer, such as renal cell carcinoma and breast cancer. Sorafenib has shown effectiveness in prolonging the time patients live without their cancer getting worse, compared to a placebo. However, this information does not relate to Ensartinib, so we cannot determine its effectiveness from the provided data.12345

What safety data exists for Ensartinib (also known as Ensacove, X-396, Ensartinib Hydrochloride) for cancer treatment?

The provided research does not contain specific safety data for Ensartinib or its other names. It focuses on other cancer treatments like avapritinib, encorafenib, lenvatinib, regorafenib, and sorafenib, discussing their adverse events and management. To find safety data for Ensartinib, further research specifically targeting this drug is needed.678910

Is the drug Ensartinib a promising treatment for cancer?

The provided research articles do not contain information about Ensartinib. They focus on a different drug called Enzalutamide, which is used for prostate cancer. Therefore, we cannot determine if Ensartinib is a promising treatment for cancer based on these articles.1112131415

What is the purpose of this trial?

This phase II Pediatric MATCH treatment trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Research Team

MS

Meredith S Irwin

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for children and young adults up to 21 years old with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific genetic changes (ALK or ROS1) and haven't responded to previous treatments. Participants need normal organ function, must be able to swallow capsules, and can't have had ensartinib before.

Inclusion Criteria

I am between 12 and 21 years old.
I have had a stem cell transplant, with or without full body radiation.
I have recovered from side effects of my previous cancer treatments.
See 15 more

Exclusion Criteria

I do not have any infections that are currently uncontrolled.
You have had an organ transplant in the past.
I am currently taking or have taken anti-cancer medication.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive ensartinib orally once daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Up to 2 years
Regular visits for imaging and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days
1 visit (in-person)

Long-term follow-up

Participants are monitored for progression-free survival and changes in tumor genomic profile

Up to 5 years

Treatment Details

Interventions

  • Ensartinib
Trial Overview The study tests how well the drug ensartinib works on patients with certain recurrent or refractory cancers. It includes various imaging studies like MRIs and bone scans to monitor the effects of the treatment which aims at blocking enzymes important for cancer cell growth.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (ensartinib)Experimental Treatment11 Interventions
Patients receive ensartinib PO QD on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study.

Ensartinib is already approved in United States for the following indications:

🇺🇸
Approved in United States as Ensacove for:
  • ALK-positive non-small cell lung cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Children's Oncology Group

Collaborator

Trials
467
Recruited
241,000+

Findings from Research

In a study involving 58 patients with metastatic renal carcinoma, sorafenib demonstrated a median progression-free survival of 7.5 months, indicating its efficacy as a second-line therapy.
However, the treatment was associated with a high rate of grade 3/4 adverse events (64%), including skin rash and hand-foot syndrome, suggesting that while effective, sorafenib may lead to significant toxicity in a broader patient population.
Sorafenib for metastatic renal cancer: the Princess Margaret experience.Riechelmann, RP., Chin, S., Wang, L., et al.[2018]
Sorafenib, the first multikinase inhibitor approved for renal cell cancer, significantly improves progression-free survival compared to placebo, highlighting its efficacy in treating advanced RCC.
However, patients experienced higher rates of adverse events with sorafenib, necessitating effective management strategies to maintain quality of life and optimize treatment outcomes.
Experience with sorafenib and adverse event management.Bellmunt, J., Eisen, T., Fishman, M., et al.[2018]
In a study of 44 patients with metastatic renal cell carcinoma, sorafenib showed promising antitumor activity, with a 48% rate of complete or partial responses and 64% of patients experiencing progression-free survival of 6 months or more.
Most patients were able to safely escalate their dose of sorafenib from 400 mg to 600 mg or 800 mg twice a day, with manageable side effects such as hypertension and skin reactions, indicating that higher doses can be tolerated and may enhance treatment efficacy.
A phase II trial of intrapatient dose-escalated sorafenib in patients with metastatic renal cell carcinoma.Amato, R., Zhai, J., Willis, J., et al.[2022]

References

Sorafenib for metastatic renal cancer: the Princess Margaret experience. [2018]
Experience with sorafenib and adverse event management. [2018]
A phase II trial of intrapatient dose-escalated sorafenib in patients with metastatic renal cell carcinoma. [2022]
First-line sunitinib or pazopanib in metastatic renal cell carcinoma: The Canadian experience. [2022]
A phase 3 tRial comparing capecitabinE in combination with SorafenIb or pLacebo for treatment of locally advanced or metastatIc HER2-Negative breast CancEr (the RESILIENCE study): study protocol for a randomized controlled trial. [2021]
Nursing care and management of adverse events for patients with BRAFV600E-mutant metastatic colorectal cancer receiving encorafenib in combination with cetuximab: a review. [2023]
A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. [2023]
Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. [2019]
Renal Disorders with Oral Tyrosine Kinase Inhibitors in Metastatic Colorectal Cancer: An Analysis from the FDA Adverse Event Reporting System Database. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Management of common adverse events in patients treated with sorafenib: nurse and pharmacist perspective. [2018]
Safety and effectiveness of enzalutamide in men with metastatic, castration-resistant prostate cancer. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Development and Validation of a Bioanalytical Method to Quantitate Enzalutamide and its Active Metabolite N-Desmethylenzalutamide in Human Plasma: Application to Clinical Management of Patients With Metastatic Castration-Resistant Prostate Cancer. [2021]
Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naïve Prostate Cancer: 1- and 2-Year Open-label Follow-up Results. [2021]
[Enzalutamide-a novel androgen receptor inhibitor that provides treatment options for patients with castration-resistant prostate cancer]. [2021]
Deep and ongoing response of castrate-resistant prostate cancer on very low-dose enzalutamide in an elderly chemotherapy-naïve patient: a case report. [2021]
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